Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 04, 2016 | |
Document and Entity Information | ||
Entity Registrant Name | T2 Biosystems, Inc. | |
Entity Central Index Key | 1,492,674 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 24,364,743 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 50,218 | $ 73,662 |
Accounts receivable | 288 | 369 |
Prepaid expenses and other current assets | 562 | 838 |
Inventories | 1,435 | 683 |
Total current assets | 52,503 | 75,552 |
Property and equipment, net | 12,815 | 10,655 |
Restricted cash | 260 | 260 |
Other assets | 331 | 358 |
Total assets | 65,909 | 86,825 |
Current liabilities: | ||
Accounts payable | 795 | 1,228 |
Accrued expenses and other current liabilities | 4,506 | 4,162 |
Current portion of notes payable | 10,631 | 4,449 |
Deferred revenue | 1,266 | 2,146 |
Current portion of lease incentives | 284 | 268 |
Total current liabilities | 17,482 | 12,253 |
Notes payable, net of current portion | 24,168 | 26,121 |
Lease incentives, net of current portion | 935 | 1,076 |
Other liabilities | 665 | 436 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2016 and December 31, 2015 | ||
Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2016 and December 31, 2015; 24,364,743 and 24,175,381 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 24 | 24 |
Additional paid-in capital | 198,992 | 195,800 |
Accumulated deficit | (176,357) | (148,885) |
Total stockholders' equity | 22,659 | 46,939 |
Total liabilities and stockholders' equity | $ 65,909 | $ 86,825 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheet (Parentheticals) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
Condensed Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 24,364,743 | 24,175,381 |
Common stock, shares outstanding | 24,364,743 | 24,175,381 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Revenue: | ||||
Product revenue | $ 151 | $ 588 | $ 10 | |
Research revenue | 839 | $ 564 | 1,498 | 743 |
Total revenue | 990 | 564 | 2,086 | 753 |
Costs and expenses: | ||||
Cost of product revenue | 1,781 | 2,807 | 3 | |
Research and development | 6,369 | 6,651 | 12,958 | 12,520 |
Selling, general and administrative | 6,143 | 4,437 | 12,347 | 8,905 |
Total costs and expenses | 14,293 | 11,088 | 28,112 | 21,428 |
Loss from operations | (13,303) | (10,524) | (26,026) | (20,675) |
Interest expense, net | (805) | (477) | (1,540) | (954) |
Other income, net | 62 | 6 | 94 | 15 |
Net loss and comprehensive loss | $ (14,046) | $ (10,995) | $ (27,472) | $ (21,614) |
Net loss per share — basic and diluted | $ (0.58) | $ (0.54) | $ (1.13) | $ (1.07) |
Weighted-average number of common shares used in computing net loss per share — basic and diluted | 24,321,310 | 20,260,591 | 24,270,041 | 20,171,051 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Operating activities | ||
Net loss | $ (27,472) | $ (21,614) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,068 | 600 |
Stock-based compensation expense | 2,527 | 1,577 |
Noncash interest expense | 308 | 180 |
Deferred rent | (123) | (67) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 81 | (188) |
Prepaid expenses and other assets | 276 | 447 |
Inventory | (752) | (453) |
Accounts payable | (49) | 827 |
Accrued expenses and other liabilities | 228 | (396) |
Deferred revenue | (879) | 1,695 |
Net cash used in operating activities | (24,787) | (17,392) |
Investing activities | ||
Purchases and manufacture of property and equipment | (3,173) | (4,184) |
Decrease in restricted cash | 80 | |
Net cash used in investing activities | (3,173) | (4,104) |
Financing activities | ||
Payment of offering costs for issuance of common stock in public offering | (385) | |
Proceeds from issuance of common stock and stock options exercises, net | 700 | 1,088 |
Proceeds from notes payable, net of issuance costs | 4,593 | |
Repayments of notes payable | (392) | (152) |
Net cash provided by financing activities | 4,516 | 936 |
Net decrease in cash and cash equivalents | (23,444) | (20,560) |
Cash and cash equivalents at beginning of period | 73,662 | 73,849 |
Cash and cash equivalents at end of period | 50,218 | 53,289 |
Supplemental disclosures of cash flow information | ||
Cash paid for interest | 1,146 | 716 |
Supplemental disclosures of noncash investing and financing activities | ||
Accrued property and equipment | $ 184 | $ 1,595 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2016 | |
Nature of Business | |
Nature of Business | 1. Nature of Business T2 Biosystems, Inc. (the “Company”) was incorporated on April 27, 2006 as a Delaware corporation with operations based in Lexington, Massachusetts. The Company is an in vitro diagnostic company that has developed an innovative and proprietary platform that enables rapid, sensitive and simple direct detection of pathogens, biomarkers and other abnormalities across a variety of unpurified patient sample types. The Company is using its T2 Magnetic Resonance platform (“T2MR”) to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. The Company’s initial development efforts target sepsis, hemostasis and Lyme disease, areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. On September 22, 2014, the Company received market authorization from the U.S. Food and Drug Administration (“FDA”) for its first two products, the T2Dx Instrument (“T2Dx”) and T2Candida Panel (“T2Candida”). The Company has devoted substantially all of its efforts to research and development, business planning, recruiting management and technical staff, acquiring operating assets, raising capital, and, most recently, the commercialization of its products. Liquidity At June 30, 2016, the Company has cash and cash equivalents of $ 50.2 million and an accumulated deficit of $ 176.4 million. The future success of the Company is dependent on its ability to successfully commercialize its FDA approved products, obtain regulatory clearance for and successfully launch its future product candidates, obtain additional capital and ultimately attain profitable operations. Historically, the Company has funded its operations primarily through its August 2014 initial public offering, its December 2015 secondary public offering, private placements of redeemable convertible preferred stock and through debt financing arrangements. The Company is subject to a number of risks similar to other newly commercial life science companies, including, but not limited to commercially launching the Company’s products, development and market acceptance of the Company’s product candidates, development by its competitors of new technological innovations, protection of proprietary technology, and raising additional capital. Having obtained authorization from the FDA to market T2Dx and T2Candida, the Company has incurred significant commercialization expenses related to product sales, marketing, manufacturing and distribution. In addition, the Company expects that costs and expenses will increase substantially as it continues the research and development of other product candidates and maintains, expands and protects its intellectual property portfolio. The Company may seek to fund its operations through public equity or private equity or debt financings, as well as other sources. However, the Company may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. The Company’s failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on the Company’s business, results of operations and financial condition and the Company’s ability to develop and commercialize T2Dx, T2Candida and other product candidates. Management believes that its existing cash and cash equivalents at June 30, 2016, together with the additional remaining liquidity of up to $5.4 million available under an Equipment Lease Credit Facility (the “Credit Facility”) entered into in October 2015 to help the Company meet its capital equipment needs (Note 5), will be sufficient to allow the Company to fund its current operating plan for at least the next 12 months. Should the Company’s current operating plans not materialize as expected, and it is unable to obtain additional capital on a timely basis, the Company may be required to change its current operating plans to reduce its future expenses, which is within its control, in order to fund operations at reduced levels for at least the next 12 months. For more information, refer to the section titled “Liquidity and Capital Resources” in Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations and the section entitled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2015, for additional risks associated with our capital needs. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2016 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as defined in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s condensed consolidated financial statem ents include the accounts of the Company and its wholly-owned subsidiary, T2 Biosystems Securities Corporation. All intercompany balances and transactions have been eliminated. Unaudited Interim Financial Information Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015. The accompanying interim condensed consolidated balance sheet as of June 30, 2016, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2016 and 2015, the condensed consolidated statements of cash flows for the six months ended June 30, 2016 and 2015 and the related financial data and other information disclosed in these notes are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2016, and the results of its operations and its cash flows for the three and six months ended June 30, 2016 and 2015. The results for the three- and six months ended June 30, 2016 are not necessarily indicative of the results to be expected for the year ending December 31, 2016, any other interim periods, or any future year or period. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision ‑making group, in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company views its operations and manages its business in one operating segment, which is the business of developing and launching commercially its diagnostic products aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method for outstanding stock options. For purposes of the diluted net loss per share calculation, stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders was the same for all periods presented. Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while each such officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is the officer’s or director’s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ liability insurance coverage that limits its exposure and enables the Company to recover a portion of any future amounts paid. The Company leases office, laboratory and manufacturing space under noncancelable operating leases. The Company has standard indemnification arrangements under the leases that require it to indemnify the landlords against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation or nonperformance of any covenant or condition of the Company’s leases. In the ordinary course of business, the Company enters into indemnification agreements with certain suppliers and business partners where the Company has certain indemnification obligations limited to the costs, expenses, fines, suits, claims, demands, liabilities and actions directly resulting from the Company’s gross negligence or willful misconduct, and in certain instances, breaches, violations or nonperformance of convenants or conditions under the agreements. As of June 30, 2016 and December 31, 2015, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. Revenue Recognition The Company generates revenue from product sales, which includes the sale of T2Dx, consumable diagnostic tests and related services, and research and development agreements with third parties. The Company recognizes revenue in accordance with FASB ASC Topic 605, Revenue Recognition (“ASC 605”). Accordingly, the Company recognizes revenue when all of the following criteria have been met: i. Persuasive evidence of an arrangement exists ii. Delivery has occurred or services have been rendered iii. The seller’s price to the buyer is fixed or determinable iv. Collectability is reasonably assured If any of the above criteria have not been met, the Company defers revenue until such time each of the criteria have been satisfied. Product revenue is generated by the sale of T2Dx and consumable diagnostic tests. The Company either sells T2Dx to customers, or retains title and places a T2Dx at the customer site pursuant to a reagent rental agreement. When a T2Dx is directly purchased by a customer, the Company recognizes revenue when all applicable revenue recognition criteria are met. When a T2Dx is placed under a reagent rental agreement, the Company’s customers generally agree to long-term agreements, certain of which may include minimum purchase commitments and/or incremental charges on each consumable diagnostic test purchased, which varies based on the monthly volume of test cartridges purchased. Revenue from the sale of consumable diagnostic tests, which includes the incremental charge, is generally recognized upon delivery as a component of product revenue in the Company’s consolidated statements of operations and comprehensive loss. Direct sales of T2Dx include warranty, maintenance and technical support services for one year following the installation of a purchased T2Dx (“Maintenance Services”). After the completion of the initial Maintenance Services period, customers have the option to renew the Maintenance Services for additional one year periods in exchange for additional consideration. In addition, the Company may provide training to customers. The Company defers revenue from the initial sale of a T2Dx equal to the relative fair value of the one year of Maintenance Services and training and recognizes the amounts ratably over the service delivery period. The Company warrants that consumable diagnostic tests will be free from defects, when handled according to product specifications, for the stated life of the product. To fulfill valid warranty claims, the Company provides a credit to its customers on future orders. Accordingly, the Company defers revenue associated with the estimated defect rates of the consumable diagnostic tests. The Company does not offer rights of return for T2Dx or consumable diagnostic tests. Shipping and handling costs incurred associated with products sold to customers are recorded as a cost of product revenue in the consolidated statement of operations and comprehensive loss. Shipping and handling costs billed to customers in connection with a product sale are recorded as a component of product revenue in the consolidated statements of operations and comprehensive loss. For multiple-element arrangements, the Company identifies the deliverables included within each agreement and evaluates which deliverables represent separate units of accounting. The determination that multiple elements in an arrangement meet the criteria for separate units of accounting requires the Company’s management to exercise judgment. The Company accounts for those components as separate elements when the following criteria are met: (1) the delivered items have value to the customer on a stand-alone basis; and, (2) if there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within its control. The consideration received is allocated among the separate units of accounting based on a selling price hierarchy. The selling price hierarchy is based on: (1) vendor specific objective evidence (“VSOE”), if available; (2) third party evidence of selling price if VSOE is not available; or (3) best estimated selling price (“BESP”) if neither VSOE nor third party evidence is available. The Company generally expects that it will not be able to establish selling price using third-party evidence due to the nature of our products and the markets in which the Company competes, and, as such, the Company typically will determine selling price using VSOE or BESP. When the Company establishes selling price using BESP, consideration is given to both market and Company-specific factors, including the cost to produce the deliverable and the anticipated margin on that deliverable, as well as the characteristics of markets in which the deliverable is sold. Revenue earned from activities performed pursuant to research and development agreements is reported as research revenue in the consolidated statements of operations and comprehensive loss, using the proportional performance method as the work is completed, limited to payments earned, and the related costs are expensed as incurred as research and development expense. The timing of receipt of cash from the Company’s research and development agreements generally differs from when revenue is recognized. Product Recall In July 2016, the Company announced its plans to initiate a voluntary recall and replacement of its T2Candida cartridges at certain customer sites because T2Candida was experiencing higher than normal invalid test rates as the T2Candida cartridges aged. As a result of this voluntary recall, the Company deferred revenue totaling $149,000 and recorded additional costs of product revenue of $41,000 related to returned products, which are no longer usable, during the three and six months ended June 30, 2016. The impact of the voluntary recall on T2Candida cartridges in inventory was not material to the condensed consolidated financial statements. Cost of Product Revenue Cost of product revenue includes the cost of materials, direct labor and manufacturing overhead costs used in the manufacture of consumable diagnostic tests sold to customers and related license and royalty fees. Cost of product revenue also includes depreciation on revenue generating T2Dx that have been placed with customers under reagent rental agreements; costs of materials, direct labor and manufacturing overhead costs on T2Dx sold to customers; and other costs such as customer support costs, royalties and license fees, warranty and repair and maintenance expense on T2Dx that have been placed with customers under reagent rental agreements. Research and Development Costs Costs incurred in the research and development of the Company’s product candidates are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including activities associated with performing services under research revenue arrangements, and include salaries and benefits, stock compensation, research related facility and overhead costs, laboratory supplies, equipment and contract services. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Standards Adopted In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs (“ASU 2015-03”). This standard amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. It is effective for annual reporting periods beginning after December 15, 2015, but early adoption is permitted. Adoption of ASU 2015-03 is applied retrospectively. The Company adopted ASU 2015-03 during the six months ended June 30, 2016, which resulted in a balance sheet reclassification of issuance costs of $22,000 recorded in prepaid expenses and other current assets and $102,000 in other assets to a reduction in the current portion of notes payable and notes payable, net of current portion as of December 31, 2015, respectively. The Company’s adoption of this standard did not have an impact on its condensed consolidated results of operations or cash flows for the three and six months ended June 30, 2016 and 2015. In April 2015, the FASB issued ASU No. 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement (“ASU 2015-05”). The standard clarifies that customers in cloud computing arrangements should determine whether the arrangement includes a license of software by applying the same guidance as cloud service providers and eliminates the existing requirement for customers to account for software licenses acquired by analogizing to the guidance on leases. It is effective for annual periods beginning on or after December 15, 2015, including interim periods within those annual periods, and early adoption is permitted. Adoption of ASU 2015-05 can either be applied (1) prospectively to all arrangements entered into or materially modified after the effective date or (2) retrospectively. The Company adopted the guidance prescribed by ASU 2015-05 prospectively, and the new guidance did not have a material effect on its condensed consolidated financial statements. Standards Issued, Not Adopted In March 2016, the FASB released ASU No. 2016-09 Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”) which is intended to simplify income tax accounting for excess tax benefits, accounting for forfeitures, and employer statutory withholding. Under the current guidance, excess tax benefits that result from an award vesting or settling are recognized in additional paid-in capital in the period that they reduce cash taxes payable. This requires the provision to be computed on a with and without option basis and may result in net operating loss and credit carryforwards on the balance sheet being less than what is available on the tax return. Under the new guidance, the income tax effects of awards will be recognized as a component of income tax expense when the awards vest or are settled (regardless if cash taxes are reduced). For interim reporting purposes, companies will account for excess tax benefits and tax deficiencies as discrete items in the period during which they occurred. The guidance is effective for public entities for fiscal years beginning after December 15, 2016, and interim periods within those years. Early adoption is permitted, however all of the guidance included in the update must be applied when adopted. The Company must use a modified retrospective transition method for adopting and record the cumulative effect of all unrecognized benefits and any change in valuation allowances at the end of the prior tax period as an adjustment to retained earnings. The Company has not elected to early adopt ASU 2016-09 and is evaluating the new guidance and the expected effect on the Company’s condensed consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-06, Derivatives and Hedging (Topic 815): Contingent Put and Call Options in Debt Instruments (“ASU 2016-06”), which applies to all issuers of or investors in debt instruments with embedded call or put options. ASU 2016-06 clarifies the requirements for assessing whether contingent call or put options that can accelerate the payment of principal on debt instruments are clearly and closely related to their debt hosts. Entities performing the assessment under the guidance of ASU 2016-06 are required to assess the embedded call or put options solely in accordance with the four-step decision process. In addition, ASU 2016-06 clarifies what steps are required when assessing whether the economic characteristics and risks of call or put options are clearly and closely related to the economic characteristics and risks of their debt hosts. ASU 2016-06 is effective for financial statements issued for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years using the modified retrospective method for existing debt instruments. The Company is evaluating the new guidance and the expected effect on the Company’s condensed consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”), which applies to all leases. Under ASU 2016-02, a right-of-use asset and lease obligation will be recorded for all leases, whether operating or financing leases, while the statement of operations will reflect lease expense for operating leases and amortization and interest expense for financing leases. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 and interim periods within those years, which is the year ended December 31, 2019 for the Company. Entities are required to use a modified retrospective approach of adoption for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements. Full retrospective application is prohibited. The Company is evaluating the new guidance and the expected effect on the Company’s condensed consolidated financial statements. In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory (“ASU 2015-11”). The standard simplifies the subsequent measurement of inventory by requiring inventory to be measured at the lower of cost and net realizable value for entities using the first-in-first out method of valuing inventory. ASU 2015-11 eliminates other measures required by current guidance to determine net realizable value. ASU 2015-11 is effective for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years and early adoption is permitted. The Company has not adopted ASU 2015-11 and does not expect the new guidance to have a material effect on its condensed consolidated financial statements. In June 2014, the FASB issued amended guidance, ASU No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”), which is applicable to revenue recognition that will now be effective for the Company for the year ending December 31, 2018, as a result of the deferral of the effective date adopted by the FASB in July 2015. The new guidance must be adopted using either a full retrospective approach for all periods presented or a modified retrospective approach. Early adoption prior to the original adoption date of ASU 2014-09 is not permitted. The new guidance applies a more principles-based approach to revenue recognition. The Company is evaluating the new guidance and the expected effect on the Company’s condensed consolidated financial statements. In 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements – Going Concern (“ASU 2014-15”), which is effective for annual periods ending after December 15, 2016. Early adoption is permitted. ASU 2014-15 provides new guidance on (1) management’s responsibility in evaluating whether or not there is substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued each reporting period and (2) related financial statement disclosures. The Company has not adopted the guidance prescribed by ASU 2014-15. If this standard had been adopted as of June 30, 2016, the Company believes that it would have concluded there was not substantial doubt about its ability to continue as a going concern. However, the Company faces certain risks and uncertainties, as further described in Note 1, “Nature of Business”, that could affect this analysis and result in additional disclosures. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements The Company measures the following financial assets at fair value on a recurring basis. The following tables set forth the Company’s financial assets carried at fair value categorized using the lowest level of input applicable to each financial instrument as of June 30, 2016 and December 31, 2015 (in thousands): Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable June 30, Assets Inputs Inputs 2016 (Level 1) (Level 2) (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable December 31, Assets Inputs Inputs 2015 (Level 1) (Level 2) (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — For certain financial instruments, including accounts payable and accrued expenses, the carrying amounts approximate their fair values as of June 30, 2016 and December 31, 2015 because of their short-term nature. At June 30, 2016 and December 31, 2015, the carrying value of the Company’s debt approximated fair value, which was determined using Level 3 inputs, including a market interest rate. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 6 Months Ended |
Jun. 30, 2016 | |
Supplemental Balance Sheet Information | |
Supplemental Balance Sheet Information | 4. Supplemental Balance Sheet Information Inventories Inventories are stated at the lower of cost or market value on a first-in, first-out basis and are comprised of the following (in thousands): June 30, December 31, 2016 2015 Raw materials $ $ Work-in-process Finished goods Total inventories $ $ Property and Equipment Property and equipment consists of the following (in thousands): June 30, December 31, 2016 2015 Office and computer equipment $ $ Software Laboratory equipment Furniture Manufacturing equipment Manufacturing tooling and molds T2 instruments and components Leasehold improvements Construction in progress Less accumulated depreciation and amortization Property and equipment, net $ $ Construction in progress is primarily comprised of equipment and leasehold improvement construction projects that have not been placed in service. T2 instruments and components is comprised of raw materials and work-in-process instruments that are expected to be used or used to produce Company-owned instruments, based on our business model and forecast, and completed instruments that will be used for internal research and development or reagent rental agreements with customers. Completed T2 instruments are placed in service once installation procedures are completed and are depreciated over five years. The Company has approximately $3.1 million and $1.9 million of Company-owned T2 instruments installed and depreciating as of June 30, 2016 and December 31, 2015, respectively. Depreciation expense for Company-owned T2 instruments placed at customer sites pursuant to reagent rental agreements is recorded as a component of cost of product revenue and totaled approximately $150,000 and $238,000 for the three and six months ended June 30, 2016, respectively. There was no depreciation expense during the three and six months ended June 30, 2015, as no T2 instruments were in service during that time period. Depreciation expense for T2 instruments used for internal research and development is recorded as a component of research and development expense. Accrued Expenses Accrued expenses consist of the following (in thousands): June 30, December 31, 2016 2015 Accrued payroll and compensation $ $ Accrued research and development expenses Accrued professional services Other accrued expenses Total accrued expenses $ $ |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2016 | |
Notes Payable | |
Notes Payable | 5. Notes Payable Loan and Security Agreement On July 11, 2014, the Company entered into a loan and security agreement (the “Note Agreement”) with two lenders to borrow up to $30.0 million for operations. The Note Agreement allows the Company to borrow amounts in two tranches, up to $20.0 million (drawn in amounts not less than $10.0 million upon closing and the remainder drawn in amounts not less than $5.0 million draws) for tranche A and up to $10.0 million for tranche B. The Company borrowed the full $30.0 million available under tranches A and B by December 31, 2015. Through December 31, 2015, the Company received proceeds of $29.7 million under tranches A and B, net of issuance costs. The amounts borrowed under the Note Agreement are collateralized by substantially all of the assets of the Company, excluding intellectual property, and bear interest at the one-month LIBOR plus 7.05% , which was 7.50% on June 30, 2016. The Company paid interest only payments on the amounts borrowed under the Note Agreement through July 31, 2016. After the interest only period, the Company will repay the amounts borrowed in equal monthly installments until the maturity date of July 1, 2019. The Note Agreement requires payment of a final fee of 4.75% of the aggregate original principal of amounts borrowed, which the Company is accruing over the term of the Note Agreement. In addition, amounts borrowed may be prepaid at the option of the Company in denominations of not less than $1.0 million, and any amounts prepaid are subject to a prepayment premium of 1.5% if prepaid prior to the first anniversary of the borrowing date, 1.0% if prepaid prior to the second anniversary of the borrowing date and after the first anniversary of the borrowing date, and 0.5% if prepaid prior to the maturity date and after the second anniversary of the borrowing date. The effective interest rate for the Note Agreement, including final fee interest and non-cash interest, is 9.9% . The Note Agreement does not include any financial covenants, but does contain a subjective acceleration clause whereby upon an event of default, which includes a material adverse change in the business, operations, or conditions (financial or otherwise) of the Company or a material impairment of the prospect of repayment of any portion of the obligations, the lender may accelerate the Company’s repayment obligations under the Note Agreement. In the event of default, the lender has first priority to substantially all of the Company’s assets. The lender has not exercised its right under this clause, as there have been no such events. The Company believes the likelihood of the lender exercising this right is remote. The Company assessed all terms and features of the Note Agreement in order to identify any potential embedded features that would require bifurcation or any beneficial conversion features. As part of this analysis, the Company assessed the economic characteristics and risks of the Note Agreement, including put and call features. The Company determined that all features of the Note Agreement are clearly and closely associated with a debt host and do not require bifurcation as a derivative liability, or the fair value of the feature is immaterial. The Company will continue to reassess the features to determine if they require separate accounting on a quarterly basis. Equipment Lease Credit Facility In October 2015, the Company signed the $10.0 million Credit Facility with Essex Capital Corporation (the “Lessor”) to fund capital equipment needs. Under the Credit Facility, the Lessor will fund capital equipment purchases presented. The Company will repay the amounts borrowed in 36 equal monthly installments from the date of the amount funded. At the end of the 36 month lease term, the Company has the option to (a) repurchase the leased equipment at the lesser of fair market value or 10% of the original equipment value, (b) extend the applicable lease for a specified period of time, which will not be less than one year, or (c) return the leased equipment to the Lessor. In April 2016 and June 2016, the Company completed the first two draws under the Credit Facility, of $2.1 million and $2.5 million, respectively. The Company will make monthly payments of $67,000 under the first draw and $79,000 under the second draw. The borrowings under the Credit Facility are treated as capital leases. The amortization of the assets conveyed under the Credit Facility is included as a component of depreciation expense. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2016 | |
Stockholders' Equity | |
Stockholders' Equity | 6. Stockholders’ Equity Stock-Based Compensation 2006 Stock Incentive Plan The Company’s 2006 Stock Option Plan (“2006 Plan”) was established for granting stock incentive awards to directors, officers, employees and consultants of the Company. Upon closing of the Company’s IPO in August 2014, the Company ceased granting stock incentive awards under the 2006 Plan. The 2006 Plan provided for the grant of incentive and non-qualified stock options and restricted stock grants as determined by the Company’s board of directors. Under the 2006 Plan, stock options were generally granted with exercise prices equal to or greater than the fair value of the common stock as determined by the board of directors, expired no later than 10 years from the date of grant, and vest over various periods not exceeding 4 years. 2014 Stock Incentive Plan The Company’s 2014 Plan, as amended in June 2016 (“2014 Plan”, and together with the 2006 Plan, the “Plans”), provides for the issuance of shares of common stock in the form of stock options, awards of restricted stock, awards of restricted stock units, performance awards, dividend equivalent awards, stock payment awards and stock appreciation rights to directors, officers, employees and consultants of the Company. Since the establishment of the 2014 Plan, the Company has only granted stock options. Generally, stock options are granted with exercise prices equal to or greater than the fair value of the common stock on the date of grant, expire no later than 10 years from the date of grant, and vest over various periods not exceeding 4 years. The number of shares reserved for future issuance under the 2014 Plan is the sum of (1) 823,529 shares, (2) any shares that were granted under the 2006 Plan which are forfeited, lapsed unexercised or are settled in cash subsequent to the effective date of the 2014 Plan and (3) an annual increase on the first day of each calendar year beginning January 1, 2015 and ending on January 1, 2024, equal to the lesser of (A) 4% of the shares outstanding (on an as-converted basis) on the final day of the immediately preceding calendar year, and (B) such smaller number of shares determined by the Company’s board of directors. As of June 30, 2016 there were 419,766 shares available for future grant under the 2014 Plan. Stock Options During the six months ended June 30, 2016, the Company granted options with an aggregate fair value of $5.8 million, which are being amortized into compensation expense over the vesting period of the options as the services are being provided. The following is a summary of option activity under the Plans: Weighted-Average Weighted-Average Remaining Number of Exercise Price Per Contractual Term Aggregate Intrinsic Shares Share (In years) Value Outstanding at December 31, 2015 $ $ Granted Exercised Cancelled Outstanding at June 30, 2016 Exercisable at June 30, 2016 Vested or expected to vest at June 30, 2016 Included in the stock options granted during the six months ended June 30, 2016 are 166,066 options to purchase common stock granted to certain executive officers of the Company that vest upon the achievement of certain performance conditions, which include the attainment of specified operating result and regulatory targets, by December 31, 2017. The Company has determined the fair value of these awards on the date of grant, and commenced recognition of expense totaling $51,000 during the six months ended June 30, 2016, as certain of the performance conditions were deemed probable in the period. The total unrecognized compensation expense on the performance-based awards deemed probable of vesting at June 30, 2016 is $211,000 . The total unrecognized compensation expense on the performance-based awards not deemed probable of vesting at June 30, 2016 is $589,000 . The Company will continually evaluate the probability of achievement of each performance condition and will commence recognition of stock-based compensation expense on these awards in the period the achievement of each performance condition is deemed probable, including a catch-up adjustment from the grant date. The weighted ‑average fair values of options granted in the six-month periods ended June 30, 2016 and 2015 were $4.90 per share and $9.53 per share, respectively, and were calculated using the following estimated assumptions: Six months ended June 30, 2016 2015 Weighted-average risk-free interest rate % % Expected dividend yield % % Expected volatility % % Expected terms years years Employee Stock Purchase Plan The Company’s 2014 Employee Stock Purchase Plan (the “2014 ESPP”) provides initially for granting up to 220,588 shares of the Company’s common stock to eligible employees. The 2014 ESPP plan period is semi-annual and allows participants to purchase the Company’s common stock at 85% of the lower of (i) the market value per share of common stock on the first day of the offering period or (ii) the market value per share of the common stock on the purchase date. Each participant can purchase up to a maximum of $25,000 per calendar year in fair market value. In May 2016, participants purchased 40,000 shares of common stock under the 2014 ESPP, resulting in proceeds to the Company of $282,000 . Stock ‑Based Compensation Expense The following table summarizes the stock-based compensation expense resulting from awards granted under stock incentive plans, including the 2014 ESPP, that was recorded in the Company’s results of operations for the periods presented (in thousands): Three months ended Six months ended June 30, June 30, 2016 2015 2016 2015 Cost of product revenue $ $ — $ $ — Research and development Selling, general and administrative Total stock-based compensation expense $ $ $ $ For the three and six months ended June 30, 2016, $37,000 and $65,000 of stock-based compensation expenses was capitalized as part of inventory or T2 instruments and components, respectively. As of June 30, 2016, there was $12.1 million of total unrecognized compensation cost related to unvested stock options granted under the Plans, including the unrecognized compensation expense of stock options with performance conditions deemed probable of vesting. Total unrecognized compensation cost will be adjusted for future changes in the estimated forfeiture rate. The Company expects to recognize that cost over a remaining weighted ‑average period of 2.8 years as of June 30, 2016. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2016 | |
Net Loss Per Share | |
Net Loss Per Share | 7. Net Loss Per Share Excluded from the calculation of diluted net loss per share applicable to common stockholders, prior to the application of the treasury stock method, were 4,167,295 and 3,295,019 shares, for the three- and six-month periods ended June 30, 2016 and 2015, respectively, related to options to purchase common shares. The shares are excluded because their effect would have been anti-dilutive for the periods presented. |
Co-Development Agreement with C
Co-Development Agreement with Canon US Life Sciences | 6 Months Ended |
Jun. 30, 2016 | |
Co-Development Agreement with Canon US Life Sciences | |
Co-Development Agreement with Canon US Life Sciences | 8. Co-Development Agreement with Canon US Life Sciences On February 3, 2015, the Company entered into a Co-Development Partnership Agreement (the “Co-Development Agreement”) with Canon U.S. Life Sciences, Inc. (“Canon US Life Sciences”) to develop a diagnostic test panel to rapidly detect Lyme disease. Under the terms of the Co-Development Agreement, the Company received an upfront payment of $2.0 million from Canon US Life Sciences, and the agreement includes an additional $6.5 million of consideration upon achieving certain development and regulatory milestones for total aggregate payments of up to $8.5 million. In October 2015, the Company achieved a specified technical requirement and received $1.5 million related to the achievement of the milestone. The Company is eligible to receive an additional $5.0 million under the arrangement, in two milestone payments of $2.0 million and $3.0 million, related to the achievement of additional development and regulatory milestones. All payments under the Co-Development Agreement are non-refundable once received. The Company will retain exclusive worldwide commercialization rights of any products developed under the Co-Development Agreement, including sales, marketing and distribution and Canon US Life Sciences will not receive any commercial rights and will be entitled to only receive royalty payments on the sales of all products developed under the Co-Development Agreement. Either party may terminate the Co-Development Agreement upon the occurrence of a material breach by the other party (subject to a cure period). The Company evaluated the deliverables under the Co-Development Agreement and determined that the Co-Development Agreement included one unit of accounting, the research and development services, as the joint research and development committee deliverable was deemed to be de minimis . The Company is recognizing revenue for research and development services as a component of research revenue in the condensed consolidated financial statements as the services are delivered using the proportional performance method of accounting, limited to payments earned. Costs incurred to deliver the services under the Co-Development Agreement are recorded as research and development expense in the condensed consolidated financial statements. The Company recorded revenue of $596,000 and $324,000 during the three months ended June 30, 2016 and 2015, respectively, and recorded revenue of $1.1 million and $377,000 during the six months ended June 30, 2016 and 2015, respectively, under the Co-Development Agreement. |
Summary of Significant Accoun14
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The Company’s financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as defined in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, T2 Biosystems Securities Corporation. All intercompany balances and transactions have been eliminated. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015. The accompanying interim condensed consolidated balance sheet as of June 30, 2016, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2016 and 2015, the condensed consolidated statements of cash flows for the six months ended June 30, 2016 and 2015 and the related financial data and other information disclosed in these notes are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2016, and the results of its operations and its cash flows for the three and six months ended June 30, 2016 and 2015. The results for the three- and six months ended June 30, 2016 are not necessarily indicative of the results to be expected for the year ending December 31, 2016, any other interim periods, or any future year or period. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision ‑making group, in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company views its operations and manages its business in one operating segment, which is the business of developing and launching commercially its diagnostic products aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method for outstanding stock options. For purposes of the diluted net loss per share calculation, stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders was the same for all periods presented. |
Guarantees | Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while each such officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is the officer’s or director’s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ liability insurance coverage that limits its exposure and enables the Company to recover a portion of any future amounts paid. The Company leases office, laboratory and manufacturing space under noncancelable operating leases. The Company has standard indemnification arrangements under the leases that require it to indemnify the landlords against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation or nonperformance of any covenant or condition of the Company’s leases. In the ordinary course of business, the Company enters into indemnification agreements with certain suppliers and business partners where the Company has certain indemnification obligations limited to the costs, expenses, fines, suits, claims, demands, liabilities and actions directly resulting from the Company’s gross negligence or willful misconduct, and in certain instances, breaches, violations or nonperformance of convenants or conditions under the agreements. As of June 30, 2016 and December 31, 2015, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. |
Revenue Recognition | Revenue Recognition The Company generates revenue from product sales, which includes the sale of T2Dx, consumable diagnostic tests and related services, and research and development agreements with third parties. The Company recognizes revenue in accordance with FASB ASC Topic 605, Revenue Recognition (“ASC 605”). Accordingly, the Company recognizes revenue when all of the following criteria have been met: i. Persuasive evidence of an arrangement exists ii. Delivery has occurred or services have been rendered iii. The seller’s price to the buyer is fixed or determinable iv. Collectability is reasonably assured If any of the above criteria have not been met, the Company defers revenue until such time each of the criteria have been satisfied. Product revenue is generated by the sale of T2Dx and consumable diagnostic tests. The Company either sells T2Dx to customers, or retains title and places a T2Dx at the customer site pursuant to a reagent rental agreement. When a T2Dx is directly purchased by a customer, the Company recognizes revenue when all applicable revenue recognition criteria are met. When a T2Dx is placed under a reagent rental agreement, the Company’s customers generally agree to long-term agreements, certain of which may include minimum purchase commitments and/or incremental charges on each consumable diagnostic test purchased, which varies based on the monthly volume of test cartridges purchased. Revenue from the sale of consumable diagnostic tests, which includes the incremental charge, is generally recognized upon delivery as a component of product revenue in the Company’s consolidated statements of operations and comprehensive loss. Direct sales of T2Dx include warranty, maintenance and technical support services for one year following the installation of a purchased T2Dx (“Maintenance Services”). After the completion of the initial Maintenance Services period, customers have the option to renew the Maintenance Services for additional one year periods in exchange for additional consideration. In addition, the Company may provide training to customers. The Company defers revenue from the initial sale of a T2Dx equal to the relative fair value of the one year of Maintenance Services and training and recognizes the amounts ratably over the service delivery period. The Company warrants that consumable diagnostic tests will be free from defects, when handled according to product specifications, for the stated life of the product. To fulfill valid warranty claims, the Company provides a credit to its customers on future orders. Accordingly, the Company defers revenue associated with the estimated defect rates of the consumable diagnostic tests. The Company does not offer rights of return for T2Dx or consumable diagnostic tests. Shipping and handling costs incurred associated with products sold to customers are recorded as a cost of product revenue in the consolidated statement of operations and comprehensive loss. Shipping and handling costs billed to customers in connection with a product sale are recorded as a component of product revenue in the consolidated statements of operations and comprehensive loss. For multiple-element arrangements, the Company identifies the deliverables included within each agreement and evaluates which deliverables represent separate units of accounting. The determination that multiple elements in an arrangement meet the criteria for separate units of accounting requires the Company’s management to exercise judgment. The Company accounts for those components as separate elements when the following criteria are met: (1) the delivered items have value to the customer on a stand-alone basis; and, (2) if there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within its control. The consideration received is allocated among the separate units of accounting based on a selling price hierarchy. The selling price hierarchy is based on: (1) vendor specific objective evidence (“VSOE”), if available; (2) third party evidence of selling price if VSOE is not available; or (3) best estimated selling price (“BESP”) if neither VSOE nor third party evidence is available. The Company generally expects that it will not be able to establish selling price using third-party evidence due to the nature of our products and the markets in which the Company competes, and, as such, the Company typically will determine selling price using VSOE or BESP. When the Company establishes selling price using BESP, consideration is given to both market and Company-specific factors, including the cost to produce the deliverable and the anticipated margin on that deliverable, as well as the characteristics of markets in which the deliverable is sold. Revenue earned from activities performed pursuant to research and development agreements is reported as research revenue in the consolidated statements of operations and comprehensive loss, using the proportional performance method as the work is completed, limited to payments earned, and the related costs are expensed as incurred as research and development expense. The timing of receipt of cash from the Company’s research and development agreements generally differs from when revenue is recognized. |
Product Recall | Product Recall In July 2016, the Company announced its plans to initiate a voluntary recall and replacement of its T2Candida cartridges at certain customer sites because T2Candida was experiencing higher than normal invalid test rates as the T2Candida cartridges aged. As a result of this voluntary recall, the Company deferred revenue totaling $149,000 and recorded additional costs of product revenue of $41,000 related to returned products, which are no longer usable, during the three and six months ended June 30, 2016. The impact of the voluntary recall on T2Candida cartridges in inventory was not material to the condensed consolidated financial statements. |
Cost of Product Revenue | Cost of Product Revenue Cost of product revenue includes the cost of materials, direct labor and manufacturing overhead costs used in the manufacture of consumable diagnostic tests sold to customers and related license and royalty fees. Cost of product revenue also includes depreciation on revenue generating T2Dx that have been placed with customers under reagent rental agreements; costs of materials, direct labor and manufacturing overhead costs on T2Dx sold to customers; and other costs such as customer support costs, royalties and license fees, warranty and repair and maintenance expense on T2Dx that have been placed with customers under reagent rental agreements. |
Research and Development Costs | Research and Development Costs Costs incurred in the research and development of the Company’s product candidates are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including activities associated with performing services under research revenue arrangements, and include salaries and benefits, stock compensation, research related facility and overhead costs, laboratory supplies, equipment and contract services. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Standards Adopted In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs (“ASU 2015-03”). This standard amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. It is effective for annual reporting periods beginning after December 15, 2015, but early adoption is permitted. Adoption of ASU 2015-03 is applied retrospectively. The Company adopted ASU 2015-03 during the six months ended June 30, 2016, which resulted in a balance sheet reclassification of issuance costs of $22,000 recorded in prepaid expenses and other current assets and $102,000 in other assets to a reduction in the current portion of notes payable and notes payable, net of current portion as of December 31, 2015, respectively. The Company’s adoption of this standard did not have an impact on its condensed consolidated results of operations or cash flows for the three and six months ended June 30, 2016 and 2015. In April 2015, the FASB issued ASU No. 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement (“ASU 2015-05”). The standard clarifies that customers in cloud computing arrangements should determine whether the arrangement includes a license of software by applying the same guidance as cloud service providers and eliminates the existing requirement for customers to account for software licenses acquired by analogizing to the guidance on leases. It is effective for annual periods beginning on or after December 15, 2015, including interim periods within those annual periods, and early adoption is permitted. Adoption of ASU 2015-05 can either be applied (1) prospectively to all arrangements entered into or materially modified after the effective date or (2) retrospectively. The Company adopted the guidance prescribed by ASU 2015-05 prospectively, and the new guidance did not have a material effect on its condensed consolidated financial statements. Standards Issued, Not Adopted In March 2016, the FASB released ASU No. 2016-09 Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”) which is intended to simplify income tax accounting for excess tax benefits, accounting for forfeitures, and employer statutory withholding. Under the current guidance, excess tax benefits that result from an award vesting or settling are recognized in additional paid-in capital in the period that they reduce cash taxes payable. This requires the provision to be computed on a with and without option basis and may result in net operating loss and credit carryforwards on the balance sheet being less than what is available on the tax return. Under the new guidance, the income tax effects of awards will be recognized as a component of income tax expense when the awards vest or are settled (regardless if cash taxes are reduced). For interim reporting purposes, companies will account for excess tax benefits and tax deficiencies as discrete items in the period during which they occurred. The guidance is effective for public entities for fiscal years beginning after December 15, 2016, and interim periods within those years. Early adoption is permitted, however all of the guidance included in the update must be applied when adopted. The Company must use a modified retrospective transition method for adopting and record the cumulative effect of all unrecognized benefits and any change in valuation allowances at the end of the prior tax period as an adjustment to retained earnings. The Company has not elected to early adopt ASU 2016-09 and is evaluating the new guidance and the expected effect on the Company’s condensed consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-06, Derivatives and Hedging (Topic 815): Contingent Put and Call Options in Debt Instruments (“ASU 2016-06”), which applies to all issuers of or investors in debt instruments with embedded call or put options. ASU 2016-06 clarifies the requirements for assessing whether contingent call or put options that can accelerate the payment of principal on debt instruments are clearly and closely related to their debt hosts. Entities performing the assessment under the guidance of ASU 2016-06 are required to assess the embedded call or put options solely in accordance with the four-step decision process. In addition, ASU 2016-06 clarifies what steps are required when assessing whether the economic characteristics and risks of call or put options are clearly and closely related to the economic characteristics and risks of their debt hosts. ASU 2016-06 is effective for financial statements issued for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years using the modified retrospective method for existing debt instruments. The Company is evaluating the new guidance and the expected effect on the Company’s condensed consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”), which applies to all leases. Under ASU 2016-02, a right-of-use asset and lease obligation will be recorded for all leases, whether operating or financing leases, while the statement of operations will reflect lease expense for operating leases and amortization and interest expense for financing leases. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 and interim periods within those years, which is the year ended December 31, 2019 for the Company. Entities are required to use a modified retrospective approach of adoption for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements. Full retrospective application is prohibited. The Company is evaluating the new guidance and the expected effect on the Company’s condensed consolidated financial statements. In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory (“ASU 2015-11”). The standard simplifies the subsequent measurement of inventory by requiring inventory to be measured at the lower of cost and net realizable value for entities using the first-in-first out method of valuing inventory. ASU 2015-11 eliminates other measures required by current guidance to determine net realizable value. ASU 2015-11 is effective for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years and early adoption is permitted. The Company has not adopted ASU 2015-11 and does not expect the new guidance to have a material effect on its condensed consolidated financial statements. In June 2014, the FASB issued amended guidance, ASU No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”), which is applicable to revenue recognition that will now be effective for the Company for the year ending December 31, 2018, as a result of the deferral of the effective date adopted by the FASB in July 2015. The new guidance must be adopted using either a full retrospective approach for all periods presented or a modified retrospective approach. Early adoption prior to the original adoption date of ASU 2014-09 is not permitted. The new guidance applies a more principles-based approach to revenue recognition. The Company is evaluating the new guidance and the expected effect on the Company’s condensed consolidated financial statements. In 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements – Going Concern (“ASU 2014-15”), which is effective for annual periods ending after December 15, 2016. Early adoption is permitted. ASU 2014-15 provides new guidance on (1) management’s responsibility in evaluating whether or not there is substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued each reporting period and (2) related financial statement disclosures. The Company has not adopted the guidance prescribed by ASU 2014-15. If this standard had been adopted as of June 30, 2016, the Company believes that it would have concluded there was not substantial doubt about its ability to continue as a going concern. However, the Company faces certain risks and uncertainties, as further described in Note 1, “Nature of Business”, that could affect this analysis and result in additional disclosures. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Measurements | |
Schedule of financial assets and liabilities at fair value on a recurring basis | The following tables set forth the Company’s financial assets carried at fair value categorized using the lowest level of input applicable to each financial instrument as of June 30, 2016 and December 31, 2015 (in thousands): Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable June 30, Assets Inputs Inputs 2016 (Level 1) (Level 2) (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable December 31, Assets Inputs Inputs 2015 (Level 1) (Level 2) (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — |
Supplemental Balance Sheet In16
Supplemental Balance Sheet Information (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Supplemental Balance Sheet Information. | |
Schedule of inventory | Inventories are stated at the lower of cost or market value on a first-in, first-out basis and are comprised of the following (in thousands): June 30, December 31, 2016 2015 Raw materials $ $ Work-in-process Finished goods Total inventories $ $ |
Schedule of property and equipment | Property and equipment consists of the following (in thousands): June 30, December 31, 2016 2015 Office and computer equipment $ $ Software Laboratory equipment Furniture Manufacturing equipment Manufacturing tooling and molds T2 instruments and components Leasehold improvements Construction in progress Less accumulated depreciation and amortization Property and equipment, net $ $ |
Components of accrued expenses | Accrued expenses consist of the following (in thousands): June 30, December 31, 2016 2015 Accrued payroll and compensation $ $ Accrued research and development expenses Accrued professional services Other accrued expenses Total accrued expenses $ $ |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Stockholders' Equity | |
Summary of stock option activity | Weighted-Average Weighted-Average Remaining Number of Exercise Price Per Contractual Term Aggregate Intrinsic Shares Share (In years) Value Outstanding at December 31, 2015 $ $ Granted Exercised Cancelled Outstanding at June 30, 2016 Exercisable at June 30, 2016 Vested or expected to vest at June 30, 2016 |
Schedule of estimated assumptions used to calculate weighted-average fair value of options granted | Six months ended June 30, 2016 2015 Weighted-average risk-free interest rate % % Expected dividend yield % % Expected volatility % % Expected terms years years |
Summary of stock-based compensation expense for stock options granted that was recorded in the Company's results of operations | The following table summarizes the stock-based compensation expense resulting from awards granted under stock incentive plans, including the 2014 ESPP, that was recorded in the Company’s results of operations for the periods presented (in thousands): Three months ended Six months ended June 30, June 30, 2016 2015 2016 2015 Cost of product revenue $ $ — $ $ — Research and development Selling, general and administrative Total stock-based compensation expense $ $ $ $ |
Nature of Business (Details)
Nature of Business (Details) - USD ($) $ in Thousands | 6 Months Ended | ||||
Jun. 30, 2016 | Dec. 31, 2015 | Oct. 31, 2015 | Jun. 30, 2015 | Dec. 31, 2014 | |
Cash and cash equivalents | $ 50,218 | $ 73,662 | $ 53,289 | $ 73,849 | |
Accumulated deficit | $ (176,357) | $ (148,885) | |||
Note Agreement 1 | Equipment lease credit facility | Maximum | |||||
Remaining borrowing capacity | $ 5,400 | ||||
Note Agreement 1 | Equipment lease credit facility | Minimum | |||||
Period over which cash resources will be sufficient to allow Company to fund current operating plan | 12 months |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Details) | 6 Months Ended |
Jun. 30, 2016segment | |
Segment Information | |
Number of Operating Segments | 1 |
Summary of Significant Accoun20
Summary of Significant Accounting Policies Product Service (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2016 | Jun. 30, 2015 | |
Product information | |||
Additional costs of product revenue | $ 1,781,000 | $ 2,807,000 | $ 3,000 |
T2Dx | |||
Product information | |||
Maintenance Services period (in years) | 1 year | ||
Additional period for Maintenance Service option (in years) | 1 year | ||
T2Candida | |||
Product information | |||
Deferred revenue additions | 149,000 | $ 149,000 | |
Additional costs of product revenue | $ 41,000 | $ 41,000 |
Summary of Significant Accoun21
Summary of Significant Accounting Policies Recent Accounting Pronouncements (Details) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
New Accounting Pronouncements or Change in Accounting Principle | ||
Prepaid expenses and other current assets | $ 562,000 | $ 838,000 |
Other assets | 331,000 | 358,000 |
Current portion of notes payable | 10,631,000 | 4,449,000 |
Notes payable, net of current portion | 24,168,000 | $ 26,121,000 |
ASU 2015-03 | Scenario, Adjustment | ||
New Accounting Pronouncements or Change in Accounting Principle | ||
Prepaid expenses and other current assets | (22,000) | |
Other assets | (102,000) | |
Current portion of notes payable | (22,000) | |
Notes payable, net of current portion | $ (102,000) |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - Total - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Assets: | ||
Restricted cash | $ 260 | $ 260 |
Total assets | 50,478 | 73,922 |
Cash | ||
Assets: | ||
Cash and cash equivalents | 2,755 | 1,520 |
Money market funds | ||
Assets: | ||
Cash and cash equivalents | 47,463 | 72,142 |
Level I | ||
Assets: | ||
Restricted cash | 260 | 260 |
Total assets | 50,478 | 73,922 |
Level I | Cash | ||
Assets: | ||
Cash and cash equivalents | 2,755 | 1,520 |
Level I | Money market funds | ||
Assets: | ||
Cash and cash equivalents | $ 47,463 | $ 72,142 |
Supplemental Balance Sheet In23
Supplemental Balance Sheet Information - Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Supplemental Balance Sheet Information | ||
Raw materials | $ 703 | $ 203 |
Work-in-process | 472 | 287 |
Finished goods | 260 | 193 |
Total inventories | $ 1,435 | $ 683 |
Supplemental Balance Sheet In24
Supplemental Balance Sheet Information - Property and Equipment and Accrued Expenses - (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Property and Equipment | |||||
Property and equipment, gross | $ 18,669,000 | $ 18,669,000 | $ 15,462,000 | ||
Accumulated depreciation and amortization | (5,854,000) | (5,854,000) | (4,807,000) | ||
Property and equipment, net | 12,815,000 | 12,815,000 | 10,655,000 | ||
Accrued expenses | |||||
Accrued payroll and compensation | 2,282,000 | 2,282,000 | 2,418,000 | ||
Accrued research and development expenses | 722,000 | 722,000 | 458,000 | ||
Accrued professional services | 597,000 | 597,000 | 542,000 | ||
Other accrued expenses | 905,000 | 905,000 | 744,000 | ||
Total accrued expenses | 4,506,000 | 4,506,000 | 4,162,000 | ||
Office and computer equipment | |||||
Property and Equipment | |||||
Property and equipment, gross | 403,000 | 403,000 | 395,000 | ||
Software | |||||
Property and Equipment | |||||
Property and equipment, gross | 697,000 | 697,000 | 632,000 | ||
Laboratory equipment | |||||
Property and Equipment | |||||
Property and equipment, gross | 4,426,000 | 4,426,000 | 4,112,000 | ||
Furniture | |||||
Property and Equipment | |||||
Property and equipment, gross | 200,000 | 200,000 | 187,000 | ||
Manufacturing equipment | |||||
Property and Equipment | |||||
Property and equipment, gross | 884,000 | 884,000 | 577,000 | ||
Manufacturing tooling and molds | |||||
Property and Equipment | |||||
Property and equipment, gross | 74,000 | 74,000 | 71,000 | ||
T2 instruments and components | |||||
Property and Equipment | |||||
Property and equipment, gross | 7,433,000 | 7,433,000 | 4,960,000 | ||
Leasehold improvements | |||||
Property and Equipment | |||||
Property and equipment, gross | 3,357,000 | 3,357,000 | 3,332,000 | ||
Construction in progress | |||||
Property and Equipment | |||||
Property and equipment, gross | 1,195,000 | $ 1,195,000 | 1,196,000 | ||
T2 Owned Instruments in Service | |||||
Property and Equipment | |||||
Estimated useful lives (Years) | 5 years | ||||
Property and equipment, gross | 3,100,000 | $ 3,100,000 | $ 1,900,000 | ||
Depreciation expense recorded as a component of cost of product revenue | $ 150,000 | $ 0 | $ 238,000 | $ 0 |
Notes Payable - Loan and Securi
Notes Payable - Loan and Security Agreement (Details) $ in Thousands | Jul. 11, 2014USD ($)trancheLender | Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Dec. 31, 2015USD ($) |
Debt Instrument | ||||
Proceeds from issuance of note payable, net | $ 4,593 | |||
Repayments of Notes Payable | $ 392 | $ 152 | ||
Note Agreement 1 | ||||
Debt Instrument | ||||
Number of lenders | Lender | 2 | |||
Maximum borrowings available | $ 30,000 | |||
Number of tranches | tranche | 2 | |||
Proceeds from issuance of note payable, net | $ 29,700 | |||
Interest rate including both the variable rate and the basis spread (as a percent) | 7.50% | |||
Final fee as a percentage of original principal amount of amounts borrowed | 4.75% | |||
Minimum amount of denomination for prepayment of borrowings | $ 1,000 | |||
Effective interest rate including final fee interest and non-cash interest (as a percent) | 9.90% | |||
Total amount borrowed | $ 30,000 | |||
Note Agreement 1 | Prior to first anniversary of borrowing date | ||||
Debt Instrument | ||||
Prepayment premium (as a percent) | 1.50% | |||
Note Agreement 1 | Prior to second anniversary and after first anniversary of borrowing date | ||||
Debt Instrument | ||||
Prepayment premium (as a percent) | 1.00% | |||
Note Agreement 1 | Prior to maturity date and after second anniversary of borrowing date | ||||
Debt Instrument | ||||
Prepayment premium (as a percent) | 0.50% | |||
Note Agreement 1 | LIBOR | ||||
Debt Instrument | ||||
Variable Interest Rate | one-month LIBOR | |||
Basis spread (as a percent) | 7.05% | |||
Note Agreement 1 | Tranche A | ||||
Debt Instrument | ||||
Maximum borrowings available | $ 20,000 | |||
Minimum amount of draw upon closing | 10,000 | |||
Minimum amount of draw after closing | 5,000 | |||
Note Agreement 1 | Tranche B | ||||
Debt Instrument | ||||
Maximum borrowings available | $ 10,000 |
Notes Payable - Equipment Lease
Notes Payable - Equipment Lease Credit Facility (Details) - Equipment lease credit facility | 1 Months Ended | 3 Months Ended | ||
Jun. 30, 2016USD ($) | Apr. 30, 2016USD ($) | Oct. 31, 2015USD ($) | Jun. 30, 2016item | |
Capital lease obligation | ||||
Maximum borrowings available | $ 10,000,000 | |||
Debt term (in months) | 36 months | |||
Repurchase price as percentage of original equipment value that the equipment under lease may be repurchased by lessee | 10.00% | |||
Number of draws | item | 2 | |||
Minimum | ||||
Capital lease obligation | ||||
Renewal term (in years) | 1 year | |||
First Draw | ||||
Capital lease obligation | ||||
Amount of draw | $ 2,100,000 | |||
Amount of monthly payment | $ 67,000 | |||
Second Draw | ||||
Capital lease obligation | ||||
Amount of draw | $ 2,500,000 | |||
Amount of monthly payment | $ 79,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
May 31, 2016 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Share-Based Compensation | ||||||
Stock-based compensation expense | $ 1,200,000 | $ 855,000 | $ 2,462,000 | $ 1,577,000 | ||
Unrecognized compensation expense | $ 12,100,000 | 12,100,000 | ||||
Performance-based awards | ||||||
Share-Based Compensation | ||||||
Stock-based compensation expense | $ 51,000 | |||||
Number of Shares | ||||||
Granted (in shares) | 166,066 | |||||
Employee Stock Purchase Plan | ||||||
Share-Based Compensation | ||||||
Shares available for grant | 220,588 | 220,588 | ||||
Percentage of full share price paid in purchase of common stock | 85.00% | 85.00% | ||||
Maximum amount of annual employee common stock purchases | $ 25,000 | |||||
Shares purchased by participants in ESPP | 40,000 | |||||
Proceeds from the issuance of shares for the ESPP | $ 282,000 | |||||
Deemed Probable of Vesting | Performance-based awards | ||||||
Share-Based Compensation | ||||||
Unrecognized compensation expense | $ 211,000 | 211,000 | ||||
Deemed Not Probable of Vesting | Performance-based awards | ||||||
Share-Based Compensation | ||||||
Unrecognized compensation expense | $ 589,000 | 589,000 | ||||
2006 and 2014 Stock Option Plans | Options to purchase common shares | ||||||
Share-Based Compensation | ||||||
Aggregate fair value of options granted | $ 5,800,000 | |||||
Number of Shares | ||||||
Outstanding, beginning of the period (in shares) | 3,484,298 | |||||
Granted (in shares) | 1,179,208 | |||||
Exercised (in shares) | (149,897) | |||||
Cancelled (in shares) | (346,314) | |||||
Outstanding, end of the period (in shares) | 4,167,295 | 4,167,295 | 3,484,298 | |||
Exercisable (in shares) | 1,907,836 | 1,907,836 | ||||
Vested or expected to vest (in shares) | 3,848,043 | 3,848,043 | ||||
Weighted Average Exercise Price Per Share | ||||||
Outstanding, beginning of the period (in dollars per share) | $ 8.79 | |||||
Granted (in dollars per share) | 8.79 | |||||
Exercised (in dollars per share) | 2.85 | |||||
Cancelled (in dollars per share) | 13.48 | |||||
Outstanding, end of the period (in dollars per share) | $ 8.61 | 8.61 | $ 8.79 | |||
Exercisable (in dollars per share) | 6.24 | 6.24 | ||||
Vested or expected to vest (in dollars per share) | $ 8.48 | $ 8.48 | ||||
Weighted-Average Remaining Contractual Term (in years) | ||||||
Outstanding (in years) | 7 years 9 months 29 days | 7 years 7 months 21 days | ||||
Exercisable (in years) | 6 years 3 months 26 days | |||||
Vested or expected to vest (in years) | 7 years 8 months 12 days | |||||
Aggregate Intrinsic Value | ||||||
Outstanding, beginning of the period | $ 14,620,000 | |||||
Exercised (in dollars) | 863,000 | |||||
Outstanding, end of the period | $ 8,186,000 | 8,186,000 | $ 14,620,000 | |||
Exercisable | 7,255,000 | 7,255,000 | ||||
Vested or expected to vest | $ 8,145,000 | $ 8,145,000 | ||||
Fair value assumptions | ||||||
Weighted average fair value of options granted (in dollars per share) | $ 4.90 | $ 9.53 | ||||
Weighted-average risk-free interest rate | 1.45% | 1.69% | ||||
Expected dividend yield | 0.00% | 0.00% | ||||
Expected volatility | 60.00% | 55.00% | ||||
Expected terms | 6 years | 5 years 10 months 24 days | ||||
2006 Stock Option Plan | Maximum | Options to purchase common shares | ||||||
Share-Based Compensation | ||||||
Expiration Period | 10 years | |||||
Vesting period | 4 years | |||||
2014 Stock Option Plan | Options to purchase common shares | ||||||
Share-Based Compensation | ||||||
Shares available for future issuance under stock incentive plan | 823,529 | 823,529 | ||||
Percentage of common shares outstanding | 4.00% | |||||
Shares available for grant | 419,766 | 419,766 | ||||
2014 Stock Option Plan | Maximum | Options to purchase common shares | ||||||
Share-Based Compensation | ||||||
Expiration Period | 10 years | |||||
Vesting period | 4 years |
Stockholders' Equity Stock-Base
Stockholders' Equity Stock-Based Compensation Expense (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 1,200,000 | $ 855,000 | $ 2,462,000 | $ 1,577,000 |
Total unrecognized compensation costs related to non-vested stock options | 12,100,000 | $ 12,100,000 | ||
Remaining weighted-average period that unrecognized compensation costs are expected to be recognized | 2 years 9 months 18 days | |||
T2 Owned Instruments in Service | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 37,000 | $ 65,000 | ||
Cost of product revenue | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 33,000 | 59,000 | ||
Research and development | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 341,000 | 297,000 | 610,000 | 577,000 |
Selling, general and administrative | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 826,000 | $ 558,000 | $ 1,793,000 | $ 1,000,000 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Options to purchase common shares | ||||
Antidilutive Securities | ||||
Anti-dilutive securities excluded from the computation of diluted net loss per share (in shares) | 4,167,295 | 3,295,019 | 4,167,295 | 3,295,019 |
Co-Development Agreement with30
Co-Development Agreement with Canon US Life Sciences (Details) | Feb. 03, 2015USD ($)item | Jun. 30, 2016USD ($)item | Jun. 30, 2015USD ($) | Jun. 30, 2016USD ($)item | Jun. 30, 2015USD ($) | Oct. 31, 2015USD ($) |
Co-Development Agreement with Canon US Life Sciences | ||||||
Revenues | $ 990,000 | $ 564,000 | $ 2,086,000 | $ 753,000 | ||
Co Development Partnership Agreement | Canon U.S. Life Sciences Inc. | ||||||
Co-Development Agreement with Canon US Life Sciences | ||||||
Upfront payment received | $ 2,000,000 | |||||
Additional consideration receivable upon achievement of certain development and regulatory milestones | 6,500,000 | |||||
Aggregate consideration receivable | $ 8,500,000 | |||||
Consideration eligible to receive upon achievement of specified technical requirement related to the achievement of the milestone | $ 1,500,000 | |||||
Additional consideration receivable upon achievement of additional development and regulatory milestones | $ 5,000,000 | $ 5,000,000 | ||||
Number of milestone payments | item | 2 | 2 | ||||
Additional consideration receivable upon achievement of development and regulatory milestones, payment one | $ 2,000,000 | $ 2,000,000 | ||||
Additional consideration receivable upon achievement of development and regulatory milestones, payment two | 3,000,000 | 3,000,000 | ||||
Number of units | item | 1 | |||||
Revenues | $ 596,000 | $ 324,000 | $ 1,100,000 | $ 377,000 |